MOJELIM Dr

Manufacturer
MOJELIM COSMEDI CO., LTD | Seoul cosmetics co.,ltd
Effective date
2017-02-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:56

Label at a glance#

ProductMOJELIM Dr
Active ingredientPYRITHIONE ZINC
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: PYRITHIONE ZINC 2.0%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients: Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Alcohol Denat, Yeast, TEA-Lauryl Sulfate, trihydroxystearin, Polyquaternium-10, Tromethamin, Parfum, Glycerin, Cocamide MEA, Tetrasodium EDTA, Panthenol, Safflower Yellow, PEG-60 Hydrogenated Castor Oil, Niacinamide, Sodium Benzoate, Sophora Angustifolia Root Extract, Paeonia Albiflora Root Extract, Tocopheryl Acetate, Salicylic Acid, PVP, Sodium Chloride, Citric Acid, Panax Ginseng Root Extract, Thuja Occidentalis Leaf Extract, Morus Alba Bark Extract, Chrysanthemum Zawadskii Extract, Lycium Chinense Fruit Extract, Acorus Gramineus Root/Stem Extract, Xanthium Strumarium Fruit Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Mentha Arvensis Extract, Biotin, Glycine, Betaine, PCA, Camellia Sinensis Leaf Extract, Saccharomyces/Rice Bran Ferment, Glycine Soja (Soybean) Seed Extract, Hydrolyzed Silk, Hydrolyzed Keratin, Houttuynia Cordata Extract, Perilla Frutescens Leaf Extract, Ginkgo Biloba Leaf Extract, Panax Ginseng Root Extract, Chamaecyparis Obtusa Water, Cysteine, Camellia Japonica Seed Oil, Olea Europaea (Olive) Fruit Oil

PURPOSE

OTC - PURPOSE SECTION

Purpose: Anti dandruff

WARNINGS

WARNINGS SECTION

Warnings: For external use only 1. Avoid using on the following area. Scalp and skin affected by eczema. 2. Be cautious in the following case. Anyone who suffered from allergies (dermatitis due to rash, flare, itchiness, and lacquer) by drug or cosmetic 3. Consult with the doctor or pharmacist after discontinuing the use in case of symptoms, such as rash, flare and itchiness, caused by the usage of the drug. 4. General caution 1) Avoid contact with eyes. In case of contact with eyes, promptly rinse with water. In case the symptom is severe, receive treatment by an ophthalmologist. 2) Use the drug only for external use and not for internal use. 5. Caution on storage 1) Avoid direct sunlight and store in a cool place if possible. 2) Do not put in other container to maintain its quality and prevent misuse. 3) Avoid the location exposed to open flame and keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

Indications & Usage: ① Prevention efficacy of dandruff by keeping the hygiene of the scalp ② May have the efficacy on hair loss prevention as well as hair thickness improvement ③ Hypo-allergenic on scalp with 23 types of natural components ④ Containing beer yeast extracts with abundant vitamin and protein ⑤ Enhancement of luster and elasticity by nourishing the scalp and hair

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Dosage & Administration: ① Wet the scalp and hair with warm water sufficiently. ② Put the adequate amount on the palm and make enough foam. ③ Gently massage the scalp with the fingertip, and the hair with the palm for 1~3 minutes. ④ Rinse the hair after 3 minutes.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
244458zinc pyrithione 2 % Medicated ShampooPSN1
244458zinc pyrithione 20 MG/ML Medicated ShampooSCD1
244458zinc pyrithione 2 % Medicated ShampooSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71194-010-022020-01-31C16284748780-19d75b9cf-fe15-f424-e053-dadaa90a57ced726fe73-5d16-4ebf-b382-463419dc54de

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71194-010-01MOJELIM Dr500 mL in 1 BOTTLE, PUMPSHAMPOO5001
71194-010-02MOJELIM Dr1 in 1 CARTONSHAMPOO11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71194-010MOJELIM DR (PYRITHIONE ZINC) SHAMPOO [MOJELIM COSMEDI CO., LTD]1Legacy NDC, 2 package rows20170227_d726fe73-5d16-4ebf-b382-463419dc54de.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71194-01071194-010-01, 71194-010-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e89a53c8-2c3e-4d1e-ac56-822b02b0477ed726fe73-5d16-4ebf-b382-463419dc54de2017-02-27WarningsExact identifier
spl id: e89a53c8-2c3e-4d1e-ac56-822b02b0477e
spl set id: d726fe73-5d16-4ebf-b382-463419dc54de

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.